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FDA roundup: Endo Pharmaceuticals Holding Inc.

FDA ROUNDUP: Endo Pharmaceuticals Holding Inc. (Chadds Ford PA) and ProStrakan Group Plc (Galashiels GBR) received marketing clearance for their Fortesta testosterone gel to treat men with low levels of the hormone. The gel is applied with one finger to each thigh, an application aimed at preventing it from rubbing off onto other people, such as children and women, which has been a concern of the U.S. Food and Drug Administration. Endo holds U.S. marketing rights to the gel. Endo's Fortesta aims to treat low testosterone levels, or hypogonadism, that can be associated with erectile dysfunction, osteoporosis and hair loss. Almost 14 million U.S. men have low testosterone levels but of those, just 9% are getting treated, it said. In May 2009, FDA called for strong warnings on such topical products after reported exposure in children following skin contact that could cause enlarged sex organs, premature pubic hair development and aggressive behavior.

Elsewhere, Merck & Co.'s (Whitehouse Station NJ) vaccine Gardasil was approved for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years. Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females. It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.

Roche Holding AG (Basel CHE) won expanded approval for its Actemra medicine as a treatment for moderate to severe rheumatoid arthritis. Actemra can be used to inhibit and slow structural joint damage and improve physical function when combined with a standard medicine, methotrexate, Roche said. Actemra won FDA clearance last year as a therapy for rheumatoid arthritis patients who haven't been helped by older treatments. The medicine is also approved in the European Union and in countries such as Japan and Australia. Actemra blocks the activity of interleukin-6, a protein that initially stimulates and later hinders the body's healing process.

And Advanced Cell Technology Inc. (Marlboro MA) was cleared to test a therapy made from embryonic stem cells in patients with macular degeneration, a leading cause of vision loss. Doctors will inject retinal cells made from stem cells into the eyes of 12 people with the so-called dry form of macular degeneration, said Gary Rabin, interim chairman and chief executive officer of the company. The disease affects about 15 million Americans and new therapies may generate as much as $30 billion in sales, Rabin said. Advanced Cell on Nov. 22 became the second company to win permission from the FDA to conduct a trial of human embryonic stem cells, in that case to treat Stargardt macular dystrophy, a rare form of macular degeneration that strikes children. The first company, Geron Corp. of Menlo Park, CA, said Oct. 11 it used embryonic stem cells to treat the first of 10 patients with spinal-cord injuries.

In other news, MannKind Corp. (Valencia CA) said the FDA needs an additional four weeks to complete review of its experimental diabetes treatment. The company said it was informed that the agency would not make a decision on whether to approve the product, a whistle-sized inhaled insulin device, by its Dec. 29 deadline. Mannkind has plenty of detractors; as of Nov. 30, roughly 24% of the company's regularly traded shares were held "short" by investors betting the stock would fall. The inhaled insulin device, known as Afrezza, has already been turned down once by the FDA, which said in March it would not approve the product until it had received more information. The company believes it has provided that information.

Johnson & Johnson (New Brunswick NJ) has halted studies of an experimental pain drug at the request of the FDA which is concerned the drug, along with others in its class, could be associated with a serious bone disorder. The company said it was advised that its drug fulranumab and others in a class known as nerve growth factor inhibitors (NGF), could be associated with a condition that can result in the need for total joint replacements. "We will work with the FDA toward resolution of this issue," said Jeffrey Leebaw, a spokesman for J&J. Leebaw said that since the mid-stage studies are still blinded, the company cannot comment on the rate of adverse events seen in the studies. J&J is not the only company's anti-NGF product to be placed on clinical hold. Last Monday, Regeneron Pharmaceuticals Inc.(Tarrytown NY) said the FDA has placed its pain drug for osteoarthritis, REGN475/SAR164877, on hold after a patient in another company's trial developed avascular necrosis of a joint. The condition is caused when bone tissue dies due to lack of blood supply, eventually causing the bone to collapse.

FDA officials are taking a closer look at recombinant human growth hormone products made by Pfizer Inc. (New York), Novartis AG (Basel CHE) and other drugmakers to see whether they increase the risk of death. The move comes on the heels of a French study that found certain children given the hormone had "a small increased risk of death" compared with the overall population, the FDA said in a statement. The move affects: Pfizer's Genotropin, Eli Lilly & Co.'s Humatrope, Novo Nordisk A/S's Norditropin, Roche Holding AG's NutropinAQ, Novartis generics unit Sandoz's Omnitrope, EMD Serono's Saizen, and Teva Pharmaceutical Industries Ltd.'s Tev-Tropin. Known chemically as somatropin, recombinant human growth hormone is an injectable protein that aims to stimulate tissue growth, height and metabolism, according to the FDA. It is used to treat a variety of conditions, including short stature in children and adults, Turner syndrome, and chronic renal insufficiency, the agency said. FDA said it was reviewing the information about the possible risk and would issue any new recommendations once it completed its review.

The FDA announced it is working with Abbott Diabetes Care Inc. (Alameda CA) to recall 359 different lots of glucose test strips marketed under the following brand names: Precision Xceed Pro; Precision Xtra; Medisense Optium; Optium; OptiumEZ; and ReliOn Ultima. These strips are used with Abbott's Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. As many as 359 million strips may be affected by the recall. The blood glucose monitoring systems are not affected by this recall. The recall pertains to certain lots of these test strips distributed in the United States and Puerto Rico. Other Abbott Diabetes Care products are not affected by the recall. The test strips being recalled may give falsely low blood glucose results. False results may lead patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading. Both scenarios pose risks to a patient's health.

And the FDA warned orthopedic device maker Smith & Nephew Plc (London GBR) that it failed to establish adequate manufacturing validation procedures for a hip replacement device. The FDA said, in a letter dated Dec. 21, that certain required tests were not performed, and the company failed to establish and maintain procedures to correct the problems. FDA inspectors found the manufacturing problems with the R3 Ceramic Acetabular Systems during an inspection of the company's facility in Tuttlingen, Germany.
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Date:Jan 10, 2011
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